50
Participants
Start Date
December 7, 2012
Primary Completion Date
May 7, 2024
Study Completion Date
May 7, 2024
Lapatinib/Temozolomide/radiation
Patients will be treated with a pulse dose of lapatinib every week and temozolomide 75 mg/m2 daily during radiation. Lapatinib will be administered beginning on the first day of radiation and temozolomide (+/-2 days). External beam fractionated regional radiation will be given on consecutive week days at 200 cGy daily doses to a total dose of 6000 cGy. Patients will have rest from temozolomide only for 2-4 weeks. Patients will continue with weekly pulse-dosing of lapatinib. After a 2-4 weeks rest(for temozolomide only) following completion of radiation therapy, temozolomide will be restarted as Cycle 1 at 150 mg/m2/day for 5 days out of every 28.Subsequent cycles can increase to 200 mg/m2/day as tolerated per investigator's judgment. Lapatinib pulse doses will be continued every week without interruption.Treatment will continue for 24 additional 28-day cycles of temozolomide if there is no evidence of progression.
UCLA, Los Angeles
Collaborators (2)
GlaxoSmithKline
INDUSTRY
Novartis
INDUSTRY
Jonsson Comprehensive Cancer Center
OTHER